MDACS Listing Overview
HK-unique listing system
MDACS listing adds a device to Hong Kong's MDIS database and issues an HKMD listing number. Only the LRP may submit a listing application.
Eligible Device Classes
| Class | Eligible? |
|---|---|
| General Class I | ❌ No |
| General Class II, III, IV | ✅ Yes |
| IVD Class A | ❌ No |
| IVD Class B, C, D | ✅ Yes |
Two Listing Routes
| Route | Description | Best For |
|---|---|---|
| Standard | Full documentation review by MDD | Devices without reference-country approvals |
| Expedited (Reliance) | Relies on prior reference-country approval | Devices with FDA, CE, TGA, Health Canada, MHRA, or PMDA approvals |
No Application Fee
The MDD does not charge a government application fee — no fee tiers, no annual charges. Budget for LRP service costs and ISO 13485 certification, but not MDD fees.
Post-Listing
Upon approval:
- HKMD number assigned and published in MDIS
- LRP assumes ongoing post-market obligations
- Listing valid indefinitely unless significant changes occur or listing is withdrawn
While no fixed renewal date applies, the MDD may conduct periodic audits, require re-attestation of ISO 13485 status, or request updated documentation if public health concerns arise or if the device remains unlisted for an extended period without market activity.
Listing Form Revamp (2026)
The MD101 (General Class II–IV) and MD102 (IVD Class B–D) listing application forms were revamped, effective 12 June 2026. Applicants should confirm they are using the current version of the relevant form before submission.